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A Research Protocol for a Phase II Single-Arm Clinical Trial Assessing the Feasibility and Efficacy of Neoadjuvant Anastrozole in Patients With Luminal Breast Cancer and Low Proliferative Index: The ANNE Trial.
Paiva, Carlos Eduardo; Silva, Alinne Tatiane Faria; Oliveira, Izabella da Silva; Guimarães, Vitor Souza; Lacerda, Domício Carvalho; Teixeira, Gustavo Ramos; Watanabe, Anapaula Hidemi Uema; Onari, Nilton; Paiva, Bianca Sakamoto Ribeiro; Oliveira-Junior, Idam de; Marques, Marcia Maria Chiquitelli; Maia, Yara Cristina de Paiva.
Afiliación
  • Paiva CE; Deparment of Clinical Oncology, Barretos Cancer Hospital, Barretos-SP, Brazil.
  • Silva ATF; Palliative Care and Quality of Life Research Group (GPQual), Barretos Cancer Hospital, Barretos-SP, Brazil.
  • Oliveira IDS; Nutrition and Molecular Biology Research Group, School of Medicine, Federal University of Uberlandia, Uberlandia, Brazil.
  • Guimarães VS; Laboratory of Nanobiotechnology Prof. Dr. Luiz Ricardo Goulart Filho, Institute of Biotechnology, Federal University of Uberlandia, Uberlandia, Brazil.
  • Lacerda DC; Palliative Care and Quality of Life Research Group (GPQual), Barretos Cancer Hospital, Barretos-SP, Brazil.
  • Teixeira GR; Palliative Care and Quality of Life Research Group (GPQual), Barretos Cancer Hospital, Barretos-SP, Brazil.
  • Watanabe AHU; Deparment of Clinical Oncology, Barretos Cancer Hospital, Barretos-SP, Brazil.
  • Onari N; Department of Pathology, Barretos Cancer Hospital, Barretos-SP, Brazil.
  • Paiva BSR; Barretos School of Health Sciences Dr. Paulo Prata - FACISB, Barretos-SP, Brazil.
  • Oliveira-Junior I; Department of Breast Radiology, Barretos Cancer Hospital, Barretos-SP, Brazil.
  • Marques MMC; Department of Breast Radiology, Barretos Cancer Hospital, Barretos-SP, Brazil.
  • Maia YCP; Palliative Care and Quality of Life Research Group (GPQual), Barretos Cancer Hospital, Barretos-SP, Brazil.
Cancer Control ; 31: 10732748241272463, 2024.
Article en En | MEDLINE | ID: mdl-39140157
ABSTRACT

INTRODUCTION:

Neoadjuvant endocrine therapy (NET) is recommended for the treatment of invasive breast cancer (BC), particularly luminal subtypes, in locally advanced stages. Previous randomized studies have demonstrated the benefits of aromatase inhibitors in this context. However, NET is typically reserved for elderly or frail patients who may not tolerate neoadjuvant chemotherapy. Identifying non-responsive patients early and extending treatment for responsive ones would be ideal, yet optimal strategies are awaited.

AIMS:

This non-randomized phase 2 clinical trial aims to assess NET feasibility and efficacy in postmenopausal stage II and III luminal BC patients, identifying predictive therapeutic response biomarkers. Efficacy will be gauged by patients with Ki67 ≤ 10% after 4 weeks and Preoperative Endocrine Prognostic Index (PEPI) scores 0 post-surgery. Study feasibility will be determined by participation acceptance rate (recruitment rate ≥50%) and inclusion rate (>2 patients/month).

METHODS:

Postmenopausal women with luminal, HER2-tumors in stages II and III undergo neoadjuvant anastrozole treatment, evaluating continuing NET or receiving chemotherapy through early Ki67 analysis after 2 to 4 weeks. The study assesses NET extension for up to 10 months, using serial follow-ups with standardized breast ultrasound and clinical criteria-based NET suspension. Clinical and pathological responses will be measured overall and in the luminal tumor A subgroup. Toxicity, health-related quality of life, and circulating biomarkers predicting early NET response will also be evaluated.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias de la Mama / Estudios de Factibilidad / Terapia Neoadyuvante / Anastrozol Límite: Adult / Aged / Female / Humans / Middle aged Idioma: En Revista: Cancer Control Asunto de la revista: NEOPLASIAS Año: 2024 Tipo del documento: Article País de afiliación: Brasil Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias de la Mama / Estudios de Factibilidad / Terapia Neoadyuvante / Anastrozol Límite: Adult / Aged / Female / Humans / Middle aged Idioma: En Revista: Cancer Control Asunto de la revista: NEOPLASIAS Año: 2024 Tipo del documento: Article País de afiliación: Brasil Pais de publicación: Estados Unidos